Lieff Cabraser Heimann & Bernstein, LLP, represents over 650 heart patients, from seniors to children, who received defective defibrillator leads manufactured by Medtronic Inc.
The Medtronic Heart Lead Recall: Updated 2010
In October 2007, Medtronic issued a recall of its Sprint Fidelis heart lead. The device is a thin electrical cable that connects an implanted defibrillator to a patient's heart which were implanted in over 200,000 patients.
When the Sprint Fidelis leads fracture, the defibrillator can fail to send a needed electrical jolt, and the patient can die. Or the defibrillator can send repeated, massive shocks, which themselves can be fatal.
In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported [login required] that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.
"The hazard of [Sprint] Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer's performance update," doctors at the University of Rochester concluded in findings published in the January 2010 issue of the American Journal of Cardiology [abstract only].
The report said the three-year survival rate of 426 Medtronic leads inserted in the hospital's patients was 90.8%, meaning 9.2% failed. In December 2009, one report estimated the failure rate of the Sprint Fidelis lead may eventually reach 30% of all patients.
Medtronic Heart Device Lawsuits
In lawsuits against Medtronic, patients represented by Lieff Cabraser have alleged that a design defect is responsible for their lead fractures. The complaints also allege that Medtronic failed to act timely as it knew of large numbers of failures of the device at least a year prior to issuing the recall.
For example, in March 2009, the New York Times reported that a previously undisclosed FDA Report indicates that Medtronic began receiving reports soon after the Sprint Fidelis heart lead was introduced to the market in late 2004 that it was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market.
Learn more:
Contact A Medtronic Recall Personal Injury Attorney | Lawyer
If you or a loved one have suffered a serious injury that your physician has confirmed was caused by a faulty Medtronic lead wire, please click here to contact an experienced personal injury attorney at the national law firm of Lieff Cabraser or call us toll-free at 1-800-948-2181. Our personal injury attorneys and legal nurse consultants will promptly review your case without charge or obligation.
Lieff Cabraser has successfully represented hundreds of patients across America who received faulty or recalled medical devices, including implantable cardiac defibrillators and pacemakers.
